Like other surgical procedures, laser surgery alters, removes, replaces, and reshapes human tissue, or it activates drugs for the purpose of treating disease and improving patient function and well being. Because laser energy possesses remarkable strength, unlike ordinary light energy, lasers are used as sophisticated surgical instruments to produce definitive and precise surgical effects.
Lasers were originally used in ophthalmology in the early 1960s, soon after the laser effect was first successfully demonstrated. Since then, many benefits of laser surgery have been demonstrated, including reduced visual loss from diabetic retinopathy, restored vision for posterior capsular opacification that occurs after cataract surgery, and reduced intraocular pressure in patients with glaucoma.
The excimer laser has been approved by the FDA for use in refractive surgery under specific terms and conditions. Adverse effects of this surgery that have occurred include corneal haze, which can limit visual acuity; visually significant irregular astigmatism; and, rarely, infection or scarring. The femtosecond laser has FDA approval for the creation of a corneal flap in patients undergoing LASIK surgery or other treatment that requires initial lamellar resection of the cornea. Another FDA-approved ophthalmic laser procedure is photodynamic therapy, which uses laser light to activate an intravenously administered drug that helps to close off abnormal blood vessels that interfere with normal retinal function.
Like other surgical instruments, lasers are potentially dangerous and can cause bleeding, edema, trauma, and tissue damage. Specific risks associated with lasers that are used for ophthalmic surgery include penetration of blood vessels with resultant bleeding; and increase in intraocular pressure with resultant damage to the optic nerve; retinal injury that includes damage to the area of central, fine vision; damage to the cornea; and cataract formation. Each of these complications could result in significant loss of vision. Because of the potentially harmful medical consequences of laser surgery, strict guidelines have been established for the use of lasers in patient care. The FDA regulates all medical instruments as prescription devices, including ophthalmic lasers.
In order to guard against potential proliferation of unsafe or inappropriate use of lasers in patient care, several surgical specialty societies have developed guidelines or policies that set forth criteria for the medical qualifications of surgeons who practice laser surgery. The guidelines also specify hospital privileges for laser surgery, residency training, and continuing medical education courses. Thus, laser surgery is subject to the same high standards of care that govern all other medical practices.
